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Synaptive Medical Secures FDA 510(k) Clearance to Extend Utilization of Robotic Exoscope with Near-Infrared Fluorescence Visualization

Thursday, March 28, 2024

Synaptive Medical, a prominent global medical technology company specializing in addressing surgical, imaging, and data-related challenges, has obtained FDA 510(k) clearance for its Near-Infrared fluorescence visualization module, known as Modus IR. This addition supplements the existing fluorescence capabilities of its 4K 3D robotic exoscope, Modus X. With this clearance, Synaptive's Modus IR becomes accessible to healthcare facilities across the United States, augmenting the comprehensive offerings of Synaptive's exoscope for deployment in neurosurgery, plastic surgery, and ear, nose, and throat (ENT) procedures.

The Modus X exoscope boasts a distinctive fluorescence functionality, leveraging custom LED lighting to seamlessly integrate white light and fluorescence views in real-time. This innovative feature facilitates simultaneous visualization of fluorescent tissues and surrounding anatomy, providing crucial anatomical context during intricate microsurgical maneuvers. Specifically designed for the visualization of indocyanine green (ICG) fluorescent dye, the newly approved IR mode aids in highlighting vessels and blood flow by causing blood to fluoresce under infrared light.

Over the past decade, Synaptive has continuously refined its platform, underscoring its commitment to advancing medical tools to support clinicians in delivering optimal patient care. The incorporation of intraoperative Near-Infrared (NIR) fluorescence visualization, alongside Synaptive's MRI and tractography-enabled neuro-navigation, enriches Synaptive's perioperative strategy for diagnosing and treating cerebrovascular conditions.

Source: globenewswire.com